Wilson-Cook Medical Inc. recalls Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemosta

Recalled October 23, 2024 · FDA recall Z-0036-2025 · Wilson-Cook Medical

Hazard

Specific lots of product have been manufactured with nonconforming raw materials. · FDA Class II

Units

UPDATE-4,605 devices

Sold at

Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Costa Rica, and Guatemala. UPDATE 1/30/2025: Foreign distribution was made to: Australia, Austria, Belgium, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Latvia, Luxembourg, Mexico, Myanmar, Netherlands, Norway, New Zealand, Poland, Portugal, Romania, Singapore, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

Description

Specific lots of product have been manufactured with nonconforming raw materials.

Product

Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.

Manufacturer(s)

Wilson-Cook Medical Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →